Season 2 Ep. 8 How to prepare for the upcoming changes with Norway Health Tech
In this episode, we are joined by Kami Faust from Norway Health Tech, to discuss what action all medical device manufacturers should take right now to prepare for the upcoming changes.
Season 2 Ep. 7 with Lasse Staal
In this episode we are joined by Lasse Staal, CEO of Danish 3D-Printing Pioneer, AddiFab, to talk about 3D-printing of medical devices.
Season 2 Ep. 6 with Ernesto Nogueira
In this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about Artificial intelligence in the medical device industry.
Season 2 Ep. 5 with Rasmus Lou-Moeller
The RoHS directive is coming! Had the pleasure of talking to Rasmus Lou-Moeller, head of R&D at Meggitt Denmark, about the RoHS directive and how it will affect the medical device industry. Through our conversation, Rasmus explained the pros and cons of the directive and gave advice to medical device manufacturers who are currently using piezoceramics in their products.
Season 2 Ep. 4 with Monir El Azzouzi
Clinical evaluation and the equivalence pathway! Are you in doubt if it is still possible to use the equivalence pathway under MDR? Are there different requirement for different classes of products? How to show equivalence under MDR. Hear practical examples based on feedback from the Notified Bodies.
Season 2 Ep. 3 with David Rutledge
Had the absolute pleasure of talking to David Rutledge about something I myself find a very difficult assessment process; Benefit - Risk Assessment.
The Benefit - Risk Assessment is mentioned 28 times during the MDR and is one of the core processes especially in the clinical evidence process. Through our conversation David made the process very tangible and I would clearly recommend listening to our conversation.
Season 2 Ep. 2 with Victor Staalkjaer and Andreas Tuxen
Starting a company within the regulatory field of medical devices contains a long series of restrictions, which at times can seem challenging. In our 2 Episode of our Qmed Consulting Podcast (Season 2), we get an insight of Victor and Andreas, experience within the Quality Management System. The two engineers have developed a Class IIa medical device. The device measures the amount of oxygen within a child under labor. It prevents unnecessary C-sections, and any complications of birth there may occur.
The Qmed Podcast gives an understanding of how to navigate in an early start-up phase of EQMS.
One of the most common challenges within start-up companies is how to get off the ground and get appropriately funded.
Questions regarding budgeting, pick of the investor, deciding the worth of one's company, and many more.
We have, therefore, in the first episode, of our new second season, invited Bjørn Broby from @Nerescue to give start-up companies a broader understanding of how to navigate in the funding process. We hope you will enjoy listening in and tap in on Bjørn's vast amount of experience.
In this final episode of our first season, Helene looks back at great interviews we've had and share some of her favourite conversations and takeaways. This is a great episode for those who are new to the podcast, but also for our avid listeners to make sure they haven't miss the important points from our talented guests. Have a great summer - See you in the fall!
The Qmed Podcast #9 with Heidi M. Mehrzad
Human factors and usability are terms often used interchangeably. Yes, it can be a tricky topic, and one that can create some confusion. Therefore, I've invited Heidi Mehrzad from HFUX Research to guide us on the difficult topic. Hope you will enjoy listening in and tap in on Heidi’s vast amount of experience.
In this episode of The Qmed Podcast we'll be joined by Richard Houlihan, to talk about "The EUDAMED database and the basic fundament behind". Being part of the European Commission MDR Eudamed technical management position Richard can provide a unique prospective on Eudamed’s inner workings and design bring a better understanding of the Eudamed technical challenges facing companies.
In this episode we are joined by Charlotte Piester from Sinua Partners and discuss how to use clinical and regulatory requirements as commercial competitive advantages within the MedTech industry, completely aligned with the changes to the MDR and the need for companies to carefully consider their claims, market access and which data to collect when – creating The Evidence Gap Plan.
In this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about key steps for SMEs to know about, regarding commercialisation when starting up the development of their innovative new medical device.
In this episode we're proud to welcome Dr. Bassil Akra. We are discussing the MDR - the new regulation and changes to come, seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.
In this episode we’re joined by Sandra Ferretti from the Obelis Group and Authorised Representative out of Brussels and we are discussing the EUDAMED database and the role of the Authorised Representative under the MDR.
In this episode we're guested by Semih Oktay, President and founder of CardioMed Device Consultants. We touch upon getting an overview of FDA structure and organisation and changes to come by June 2019, Risk classification, FDA approval processes and more.
In the first episode of The Qmed Podcast we’re joined by Hilde Viroux, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.